Prescription drug compliance monitoring system

ABSTRACT

The drug compliance monitoring system provides a patient with a portable medication dispenser programmed with medication-taking data. The dispenser alerts the patient to take a dose of medication and gathers compliance data relating to the medication-taking data. The compliance data is accessible to a physician, or other caregiver, etc., via a network database.

This application is a continuation-in-part of U.S. application Ser. No. 10/670,595, filed Sep. 25, 2003, which claims the benefit of U.S. Provisional Application No. 60/411,013, filed Sep. 26, 2002. The entire content of both applications is incorporated herein by reference.

BACKGROUND

The present invention relates generally to healthcare monitoring systems and methods and, more particularly, to a system and method for dispensing and monitoring medication for healthcare treatment.

A 1995 American Association of Retired Persons study reported that Americans age 65 and older are taking an average of 2.4 prescription drugs, while those age 50-64 take an average of 1.7 prescription drugs. It is also reported that 40% of those failed to follow their physician's dosage instructions. The Healthcare Compliance Package Council states that of the 1.8 billion prescriptions per year dispensed in the U.S., 50% are not correctly taken. The article that discussed this topic was featured in the September 1998 edition of the Packaging Digest Magazine. From the same source it is also reported that more than 80% of the current 36.3 million people over age 65 in the United States, a number that is sure to increase, are on some type of prescription medication-taking regimen. According to the National Medical Expenditure Survey, in 1987, 90 million Americans suffered from one or more chronic conditions. Treatment of these chronic conditions represents over 76% of healthcare expenditures, and the total direct cost of treating these chronic conditions is estimated to rise to $798 billion in 2030.

These statistics clearly depict the usefulness of a system to help patients comply with their medication-taking regimen while limiting their risk of potential adverse complications. As a result of compliance, the patient is in a better position to control their treatment recovery time. Remembering to accurately take medication on time and correctly is well understood to be a very serious health problem, particularly for the elderly and patients with chronic conditions for whom the intake of many different drugs is common. Failure to comply with medication-taking regimens is associated with deterioration of health status, as well as an increase in preventable fatalities. The annual cost related to non-compliance with medication-taking regimens was estimated to be in excess of $100 billion in 1998.

The drop off rate for refilling medications for chronic diseases is very high, with up to 75% of monthly prescriptions not refilled after one year. Forgetfulness to self-administer the prescribed medication at the correct intervals and correct dosages by the patients has long been found to be a major hurdle for doctors in determining the effectiveness of prescriptions. It is also well known that the more frequently a medication must be taken, the more likely the patient's compliance rate will drop. For patients who must take three, four or even five dosages of several medications daily, the prescribed regimen can easily become confusing. Many patients resort to carrying daily timetables—pill containers that sort out the medication by day of the week, or they even rely on somebody else to tell them when to take their medication. This can be effective but does not eliminate the possibility of the patient becoming distracted or simply forgetful in addition to the lack of a reliable compliance record.

Various devices for assisting patients in following medication-taking regimens are known. For example, U.S. Pat. No. 6,294,999 to Yarin et al. describes a smart tray with a plurality of medication containers equipped with electromagnetic tags that provides various information about medication contained within a respective container. The smart tray is equipped with a processor and reader that interrogates each respective electromagnetic tag to identify medication contained within each container. Using the retrieved information, a smart tray provides visual and/or audio signals to a patient to remind the patient when and how much of various medicaments to take. The device can also communicate with one or more third parties, such as healthcare providers, pharmacies, and other suppliers of healthcare products and services via a computer network. In addition, a smart tray can communicate with various appliances and can modify medication regimens for particular situations in response to data received from various appliances.

U.S. Pat. No. 5,020,037 to Raven discloses an alarm pillbox which cancels the alarm when a compartment lid is opened. A visual display is used to indicate the number of times that the lid has been opened within one day.

U.S. Pat. No. 5,408,443 to Weinberger describes a medication-dispensing system that includes a prescribing data entry station for use by a physician to store prescription information in a portable prescribing module, a dispensing data entry station for use by a pharmacy to store dispensing information in a portable dispensing data storage unit, and a medication dispenser responsive to information stored in the portable prescribing module to describe use of medication in the dispenser in accordance with a regimen prescribed by the physician and to the dispensing data storage unit to control dispensing of the medication. One embodiment has two medication drawers each having a plurality of compartments with indicating lights selectively indicating the compartment from which medication is to be taken, a screen for displaying instructions regarding loading of the medication compartments and taking of the medication, and a keyboard for confirming compliance with the instructions. Another embodiment has a series of medication-containing compartments, each covered by a separate sliding or folding cover.

U.S. Pat. No. 4,911,327 to Shepherd et al., describes a dispenser for providing scheduled dosages of pills according to a predetermined medication program. A housing contains a plurality of pill containers from which dosages of pills may be released into a user-accessible pill receiver. The release of pills is controlled such that pills are released at predetermined intervals as dictated by the medication program. On release of a dosage of pills, an alarm is activated to indicate to a user that a dosage is due to be taken, the alarm being deactivated when the user accesses the pill receiver to remove the dosage of pills. If the user does not access the pill receiver within a predetermined time interval from release of the dosage, an optional remote alarm may be activated to alert a supervisor.

U.S. Pat. No. 5,239,491 to Mucciacciaro describes a holder having a plurality of recesses for holding a plurality of medication containers, each fitting into a unique recess. The geometry of the bottom of each medication container is unique and only matches one recess in the holder. A sensor in each recess signals the presence or absence of the dedicated container to a microprocessor. The microprocessor is programmed with the prescribed dose administration schedule for each of the different medications in the different containers. A real time clock cooperates with the microprocessor and the program to signal audibly and visibly by a light in the appropriate container when a particular pill should be administered. The signals stop when the appropriate container is removed from its recess. A different warning sound indicates when the wrong container is lifted.

U.S. Pat. No. 4,837,719 to McIntosh describes a medication clock for signaling the times that dosages of a medication should be taken. The McIntosh device also provides a record of when each medication was taken for comparison with the medication schedule. In addition, the McIntosh device can monitor and record temperature, blood pressure and pulse rate of the user.

U.S. Pat. No. 4,616,316 to Hanpeter et al. describes a medication compliance monitoring system consisting of a blister pack having an array of plastic blisters defining compartments for medication. The blister pack has a frangible non-conductive backing sheet including conductive traces behind the compartments, which are respectively ruptured when the medication doses are removed. An electronic memory circuit detects when individual compartments are ruptured and stores this information.

E-pill (www.epill.com) offers a pager system that sends reminders to patients to take their medication at a specific time of the day. Carebridge (www.carebridge.net) provides an electronic timing device that patients can use to help them remember to take their medication.

IBV Technologies (Seattle, Wash.) provides a medication vial that records the time a patient takes his/her medication when a button is pressed by the patient. When returned to a pharmacy for a refill, the pharmacist can download and review a compliance report from the vial and counsel the patient regarding medication compliance.

APREX (Union City, Calif.) provides a telemedline service for monitoring medication compliance. Patients take their medication from medication containers outfitted with caps that have a microcomputer therein. When patients remove the cap from a bottle to take a dose of the medication contained therein, the microcomputer records the time and date of the dosing event. At the end of the day, patients place their medication bottles on a specially configured modem that transmits daily dosing information to a selected healthcare provider. If the healthcare provider detects a problem in how or when patients are taking their medication, specially trained healthcare providers call those patients the next day.

The MediMonitor, available from InforMedix, Inc. (Rockville Md.), is configured to retain a month supply of up to five medications in individual compartments and alerts patients when and how to take the medications. The MediMonitor also monitors medication use and health status by providing a date and time-stamped record of a patient's medication-taking behavior together with patient responses to specific questions. MediMonitor can transmit information via an internet-accessible server and database to clinical drug trial sites, physicians, pharmacies and other healthcare providers. Healthcare providers can communicate information, as well as reminders and specific instructions, directly to patients via the MediMonitor.

Unfortunately, existing devices for assisting patients in following medication-taking regimens can be somewhat non-accessible to the public due to price and difficult to use because of their complexity. Furthermore, existing devices for assisting patients in following medication-taking regimens can seem somewhat intrusive to a user.

BRIEF SUMMARY OF THE INVENTION

The present invention is directed to a system and method for aiding with compliance of a medication-taking regimen and improving self-reliance and independence of patients. A base station and portable cap assembly attached to a medication container assist the user in remembering to take medication at different period intervals during the course of complying with a medication-taking regimen. The system is also capable of storing in memory the specific time and date of an event for later retrieval by a caregiver.

The present invention may facilitate compliance with medication regimens, especially complex regimens involving multiple medications. As such, the present invention may reduce medication errors made by patients such as forgetting to take a dosage, confusing dosage times, taking more medication or various combinations thereof.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a conceptual block diagram illustrating an example medication compliance system.

FIG. 2 is a block diagram further illustrating the example medical compliance system of FIG. 1.

FIG. 3 is a Main Menu screen.

FIG. 4 is a System screen.

FIG. 5 is a Set Time/Date screen.

FIG. 6 is a Set Caregiver Phone # screen.

FIG. 7 is a Set ISP Information screen.

FIG. 8 is a System Info screen.

FIG. 9 is a Select Patient screen.

FIG. 10 is a Patient Medication screen.

FIG. 11 is a Medication History screen.

FIG. 12 is a Medication Detail screen.

FIG. 13 is an exploded view of an example portable medication dispenser.

FIG. 14 is a side view of the portable medication dispenser of FIG. 13.

FIG. 15 is a conceptual block diagram illustrating another example medication compliance system.

FIG. 16 is a conceptual block diagram illustrating another example medication compliance system.

FIG. 17 is a conceptual block diagram illustrating another example medication compliance system.

FIG. 18 is a conceptual block diagram illustrating another example medication compliance system.

FIG. 19 is an exploded view of another example portable medication dispenser.

FIG. 20 is a cross-sectional view of the example portable medication dispenser of FIG. 19.

FIGS. 21A and 21B are block diagrams further illustrating the example portable medication dispenser of FIG. 19.

FIG. 22 is a block diagram further illustrating the example portable medication container of FIG. 19.

DETAILED DESCRIPTION

FIG. 1 is a conceptual block diagram illustrating an example medical compliance system 10 according to the present invention. System 10 includes portable medication dispenser 12 having cap 14, collar 16, and container 18; communication link 20; base station 22 having LCD 24 and user interface keys 26; communication link 28; network 30; line 32; data server 34; communication link 36; remote terminal 38; communication link 40; remote terminal 42; line 44; and programming base 46.

Dispenser 12 is comprised of cap 14 which is removably attached to collar 16. Collar 16 is removably connected to the opening of container 18. Three dispensers 12 are shown in FIG. 1. One is shown with cap 14 attached to collar 16. Two are shown with cap 14 detached from collar 16.

Cap 14 communicates with base station 22 by communication link 20. In the illustrated example, base station 22 has LCD 24 and a bank of user interface keys 26. Base station 22 communicates with data network 30 via line 28. Data network 30 is also linked to data server 34 by line 32, remote terminal 38 by line 36, and remote terminal 42 by line 40. Remote terminal 42 communicates with programming station 46 through line 44. FIG. 1 also includes an inverted container 18 attached to collar 16, which couples to programming station 46.

For simplicity, the present invention will be described in the context of a physician prescribing a medication to a patient. However, the invention may be used by any health care provider or other party wishing to induce and/or track a person's compliance with a medication-taking regimen.

In the illustrated example, collar 16 contains memory and is connected to container 18 and then coupled with programming station 46 such that medication-taking data is downloaded to collar 16. Medication-taking data includes a medication-taking regimen and prescription information, the patient's name, the physician's name, or any other data that may be required. The physician calls the prescription in to a pharmacist that is equipped with remote terminal 42 linked to programming station 46, or the details of the prescription may be entered manually by the caregiver or pharmacist. The pharmacist inserts collar 16 into programming station 46 and enters the medication-taking data into remote terminal 42, which subsequently downloads the data through line 44 and programming station 46 to collar 16. The connection represented by line 44 is preferably an interface cable making contact between remote terminal 42 and programming station 46. Container 18 is subsequently filled with medication, cap 14 is attached to collar 16, and dispenser 12 is given to the patient.

In some embodiments, cap 14 contains a microcontroller, an indicator, a sensor, and communication means. In such embodiments, the microcontroller accesses the medication-taking regimen stored in the memory of collar 16, when the two are attached, to activate the indicator when the patient should take a dose of medication. It also gathers compliance data from the sensor, which senses if the patient is complying with the medication-taking regimen. The compliance data is also stored in the memory of collar 16.

The patient is equipped with base station 22. When linked by link 20, cap 14 transmits the medication-taking data along with the compliance data to base station 22. Preferably, link 20 is a form of wireless communication, such as infrared light emitting diode, radio frequency, such as communication according to the Bluetooth specification, near magnetic field, etc. Base station 22 then transmits the compliance data through line 28 to network 30, which uses data server 34 to store all of the data. Line 28 may be any type of wired or wireless link for communication with a network, such as the Internet, Intranet, a Wide Area Network (WAN), or a Local Area Network (LAN).

The physician can subsequently access the compliance data from a remote location. The physician uses remote terminal 38 to access the data from network 30 through link 36, which again is any type of communication link. Thus, an outside party, such as a physician, can determine if the patient is complying with the medication-taking regimen. In an alternative embodiment, remote terminal 42 may be used to both input the medication-taking data to collar 16 and access the compliance data. In either instance, access to compliance data is greatly simplified for both the physician and patient.

FIG. 2 is a block diagram further illustrating the cap 14, collar 16, base station 22, and programming station 46 of the example medical compliance system of FIG. 1. Cap 14 and collar 16 form a portable cap assembly. In the illustrated example, collar 16 includes memory 48 and connectors 50 and 52, while cap 14 includes microcontroller 54, connector 56, IR transmitter 58 a, IR receiver 58 b, sensor 60, battery 62, audio indicator 64, and visual indicator 66. Base station 22 includes LCD 24, user interface keys 26, modem 28 a, interface 28 b, microcontroller 68, IR transmitter 70 a, IR receiver 70 b, power supply 72, speaker 74, LED 76, and back up battery 78. Programming station 46 includes interface 44 a, microcontroller 80, power supply 82, connector 84, power LED 86, and status LED 88.

The patient keeps base station 22 at their residence. Power supply 72 powers base station 22 through an AC outlet, and backup battery 78 when power is cut off. Base station 22 has either or both modem 28 a and interface 28 b for wired or wireless connection to network 30. Various screens are displayed on LCD 24 for programming and displaying data and instructions for complying with the medication-taking regimen. These are discussed in further detail below.

A pharmacist receives a prescription for a medication-taking regimen from a physician. In some embodiments, collar 16 is detached from cap 14 and placed adjacent the opening of container 18. Collar 16 comes in a variety of sizes to accommodate various sized openings of containers 18, and both collar 26 and container 18 may be disposable and only used once. Container 18 with collar 16 is then coupled to programming station 46 (FIG. 1), which is linked to remote terminal 42 via interface 44 a. Collar 16 and programming station 46 communicate via connectors 50 and 84, respectively. Connector 50 is preferably a 4-pin connector. Power LED 86 indicates whether there is adequate power to supply programming station 46, and status LED 88 indicates whether collar 16 is properly inserted into programming station 46.

The pharmacist inputs the medication-taking data to memory 48 of collar 16. Container 18 is filled with a medication, and cap 14 is attached to collar 16. Cap 14 is reusable and can be used for more than one use. Dispenser 12, consisting of container 18, collar 16, and cap 14, is given to the patient. In some embodiments, as discussed below, the pharmacist may alternatively be able to download the medication-taking data to base station 22, which would subsequently transmit the information to dispenser 12.

The patient places dispenser 12 in the vicinity of base station 22 so that cap 14 communicates with base station 22 through wireless communication link 14 (FIG. 1). In some embodiments, wireless communication is via an infrared light emitting diode. To this end, cap 14 is equipped with IR transmitter 58 a and IR receiver 58 b, and base station 22 is equipped with IR transmitter 70 a and IR receiver 70 b. Any type of communication link may be used, but wireless communication is preferred. For example, in other embodiments, cap 14 and base station 22 communicate via RF communication. Such communication may be according to, as examples, the Bluetooth specification, the Wibree specification, or any of the IEEE 802.11 specifications. All of the medication-taking data may be transmitted to base station 22.

Collar 16 and cap 14 communicate through connectors 48 and 56, respectively. Battery 62 powers cap 14. Microcontroller 54 reads and carries out the medication-taking regimen stored in memory 48. When it is time for the patient to take a medication, either or both of audio indicator 64 and visual indicator 66 are activated. Indicators may be of any type that will alert the patient that a dose of medication should be taken and include audio, visual, and tactile indicators. Indicators 64 and 66 are activated for 15 minutes or until sensor 60 receives a signal indicating compliance. Preferably, audio indicator 64 is a buzzer that emits a 200 ms buzz every 30 seconds, and visual indicator 66 is an LED that blinks at a rate of 1 Hz, 25% duty cycle. Either of indicators 64 and 66 may also indicate low battery life.

When cap 14 is within range of communicating with base station 22 and it is time to take a dose of medication, cap 14 instructs visual indicator 76 to activate similarly to visual indicator 66. Accordingly, audio indicator 74 is instructed to activate similarly to audio indicator 64. Base station 22 may also be equipped with a speaker, not shown, that provides a synthesized voice to remind the patient to take their medication.

If the patient takes the medication within the allotted time for compliance, sensor 60 senses that a dose of medication was taken. Microcontroller 54 notes that a dose of medication was taken and stores the date and time in memory 48. In most cases, sensor 60 detects inferentially that a dose of medication was taken by noting some form of handling of container 18. For example, sensor 60 may detect the opening/closing of dispenser 12 or that dispenser 12 was inverted. Any means for sensing and generating a detectable electrical signal may be used.

If sensor 60 does not sense that a dose was taken, microcontroller 54 notes that the patient did not comply with the medication-taking regimen. The time of non-compliance is noted and stored in memory 48. If the missed medication dose is taken at a later time, that time is noted and stored in memory 48. Data from sensor 60 is the compliance data, which is subsequently transmitted to base station 22.

In the illustrated example, base station 22 has user interface keys 26, preferably four keys adjacent to LCD 24, for navigating the various screens. Keys 26 operate as soft keys, such that the function of each key changes based on the screen that is displayed. After a power-up and a splash screen are displayed, a Main Menu screen is displayed as shown in FIG. 3. The Main Menu screen always updates the current date and time. The Main Menu screen also shows messages to the patient when necessary (i.e. George Bush take 2 tablets of Claritin).

When the patient presses the System key on the Main Menu screen, the System screen shown in FIG. 4 is displayed. The System screen lists various system settings that the patient can edit. One system setting in the list is highlighted at a time, and Up Arrow and Down Arrow keys move the highlight up and down the list, respectively. The Main Menu key returns to the Main Menu screen.

To set the time and date, the patient moves the highlight to “time/date” and presses the Select key. The Set Time/Date screen is displayed as shown in FIG. 5. The patient presses the Right Arrow key to move the highlight through the modifiable fields. When the patient presses the + key and − key, the currently highlighted field will change values accordingly.

The patient chooses between a 12 hour or 24 hour format, selects the correct time zone, and sets the date and time for the real time clock chip that is part of microcontroller 68. Once the real time clock is set, the patient presses the OK key to update the time settings and return to the System screen. Base station 22 may also be programmed to retrieve the time and date from server 34 once it is plugged into network 30.

Next, from the System screen, the patient selects “caregiver phone #,” and the Set Caregiver Phone # screen is displayed, as shown in FIG. 6. The Set Caregiver Phone # screen displays the telephone number of the primary caregiver in case they need to be contacted. When initially entered, the first character of the area code is highlighted. The patient presses the + key and − key to change the value of the highlighted character. The Right Arrow key moves the highlight to the next character. When finished, the patient presses the Ok key to update the caregiver telephone number and return to the System screen.

The patient must then provide information regarding the Internet service provider (ISP) by selecting “ISP information.” Once selected, the Set ISP Information screen is displayed as shown in FIG. 7. The patient must set the telephone number, login, and password for the ISP that transfers the data to the server application.

When initially entered, the first character of the area code is highlighted. The + key and − key change the value of the currently highlighted field accordingly. The Right Arrow key moves the highlight to the next modifiable field. The patient presses the Ok key to update the ISP information and return to the System screen.

The patient may also view “system information” for base station 22 by selecting it on the System screen. When selected, the System Information screen is displayed as shown in FIG. 8. The System Information screen displays the firmware version, build number, and serial number of base station 22. The patient presses the Ok key to return to the System screen. Base station 22 is ready once the updates are set.

The medication-taking and compliance data are viewable on base station 22. When the Select Patient key is pressed on the Main Menu screen the Select Patient screen is displayed as shown in FIG. 9. System 10 can be used for a plurality of patients each taking a plurality of medications. When initially entered the first patient in the list is highlighted, and the patient presses the Up Arrow key and the Down Arrow key to move the highlight up and down the list, respectively. When the patient presses the Select key, the Patient Medication screen is displayed for the currently highlighted patient. The Main Menu key is pressed to return to the Main Menu screen.

The Patient Medication screen is shown in FIG. 10. The Patient Medication screen lists all the medications that the selected patient is taking. It also includes compliance data for each medication. The first medication in the list is initially highlighted, and the patient presses the Up Arrow key and Down Arrow key to move the highlight. When the patient presses the Select key, the Medication History screen is displayed for the selected medication. Pressing the Back key returns to the Select Patient screen.

FIG. 11 shows the Medication History screen, which lists all the dosages that have been taken and missed (compliance data). The first dose information is highlighted when the Medication History screen is initially entered, and the patient can press the Up Arrow and Down Arrow keys to move the highlight. When the Details key is pressed, the Medication Detail screen is displayed. The Back key displays the Patient Medication screen.

The Medication Detail screen is shown in FIG. 12. The Medication Detail screen lists all the medication-taking data and a summary of the compliance data. The Up Arrow and Down Arrow keys move the highlight up and down the list. The Back key displays the Medication History screen. With this and all the screens described for base station 22, five minutes of inactivity results in the Main Menu screen being displayed.

Base station 22 is connected to network 30 by either modem 28 a or interface 28 b, and base station 22 may be equipped with either or both. The physician can subsequently retrieve the compliance data whenever it is convenient to do so without having to wait for data from the patient or having to travel to the patient. Proprietary software allows the physician, caregiver, etc., to view the information sent by base station 22. The software is designed with the ability to generate custom reporting. In addition, the compliance data generated by the present invention is much more reliable than the patient's memory or relying on the patient to note compliance.

FIG. 13 shows an example configuration of dispenser 12 in more detail. Dispenser 12 includes container 18, collar 16, and cap 14. Collar 16 further includes memory 48, connector 56, magnet 60 b, stationary base 90, and pivoting base 92. Cap 14 further includes connector 52, IR transmitter 58 a, IR receiver 58 b, switch 60 a, battery 62, audio indicator 64, LED lamp 66 a, illuminated disc 66 b, board 94, battery clip 96, and top 98.

Collar 16 attaches to container 18. Memory 48 and connector 56 are mounted on pivoting base 92. Cap 14 attaches to collar 16. In this manner, collar 16 is located between cap 14 and the opening of container 18. Connector 52, switch 60 a, LED lamp 66 a, and illuminated disc 66 b are mounted on the underside of board 94. IR transmitter 58 a and IR receiver 58 b are mounted on the topside of board 94 near battery 62 and audio indicator 64. Microcontroller 44 (not shown) is also mounted on board 94. Battery clip 96 holds battery 62, or battery 62 may be mounted to board 94. Top 98 covers the internal components of cap 14.

In operation, container 18 is filled with medication, and collar 16 with cap 14 is attached adjacent the opening of container 18. When it is time for the patient to take a dose of medication, LED lamp 66 a is activated to illuminate illuminated disc 66 b, and/or audio indicator 64 is activated to notify the patient. The patient simply presses down on cap 14 such that pivoting base 92 pivots relative to stationary base 90 of collar 16 as shown in FIG. 14. In this manner, pivoting base 92 moves relative to stationary base 90 from a first position in which the opening of container 18 is substantially covered to a second position in which the opening is exposed to allow the patient to dispense the medication in the container. FIG. 14 shows shaded region 100, which is the pivot range for opening dispenser 12. Preferably, the pivot range is about 0.4 in. The patient dispenses a dose of medication and closes the portable cap assembly.

Switch 60 a and magnet 60 b form sensor 60 for sensing the opening/closing of dispenser 12. Switch 60 a may be a dry reed switch. As pivoting base 92 pivots open, switch 60 a changes state to generate an electrical signal by contacting magnet 60 b. When pivoting base 92 returns to its original position, switch 60 a is no longer in contact with magnet 60 b, and the signal stops. Thus, microcontroller 54 automatically knows that the patient complied with the medication regimen without the patient having to remember to indicate that a dose was taken.

Top 98, in the present embodiment, is transparent to allow for passage of IR signals. If another means of wireless communication is utilized, top 98 does not need to be transparent. Top 98 may also be equipped with a childproof lock mechanism.

FIG. 15 is a block diagram of another example embodiment of medication compliance system according the present invention. Medication compliance system 101 includes portable medication dispensers 104A-104N (collectively referred to as “portable medication dispensers 104”) having caps 114A-114N (collectively referred to as “caps 114”), collars 116A-116N (collectively referred to as “collars 116”), and containers 118A-118N (collectively referred to as “containers 118”).

Portable medication dispensers 104 may be communicatively coupled to a base station 102 via communication links 146. Communication links 146 may be RF communication links following, as examples, the 802.11 WIFI (Wireless Fidelity), Bluetooth or Wibree protocols. Other wireless communication links may be used such as, but not limited to links according to other RF communication protocols, or links involving infrared light emitting diodes or near magnetic field induction. Furthermore, communication links 146 need not be wireless. Additionally, one communication link 146 may be different from another communication link 146. For example, portable medication dispenser 104A may be communicatively coupled to base station 102 using the 802.11 WIFI standard, and portable mediation dispenser 104B may be communicatively coupled to base station 102 via the Bluetooth protocol.

Base station 102 may be any device capable of communication with dispensers 104 and a network 100. For example, base station 102 may take the form of a computing device, such as base station 24 illustrated in FIGS. 1 and 2, or a general purpose personal or laptop computer. As other examples, base station 102 may take the form of a handheld device such as a cellular phone, a personal digital assistant (PDA), or the like. Furthermore, base station 102 may take the form of a home health monitor or other medical device, such as a insulin monitor, scale, heart rate monitor, external defibrillator, or drug pump. As another example, base station 24 may take the form of a wireless access point for a home, office, or medical facility network. Although illustrated in FIG. 15 as including a single base station 102, medication compliance systems according to the invention may include any number of base stations of any type.

Base station 102 may be communicatively coupled to network 100 via a communication link 147. Communication link 147 may comprise an RF communication link following, as examples, the 802.11 WIFI (Wireless Fidelity) or Bluetooth protocols. As other examples, communication link 146 may include an Ethernet connection, modem connection, Wireless Application Protocol (WAP) link, or cellular telephone link. Network 100 may include, for example, one or more of the Internet, an Intranet, a Wide Area Network (WAN), a Local Area Network (LAN), or a cellular telephone network.

Via network 100, base station 102 may be coupled to one or more computing devices or locations, such as one or more computing devices associated with a pharmacy 106 or a health care provider 108, such as a physician. Furthermore, base station 102 may be coupled to a server 110 via network 100. Server 110 may facilitate communication between one or more of base station 102, pharmacy 106 and health care provider 108, such as communication of medication-taking data and compliance data. Server 110 may also provide or be coupled to a database for storing information regarding one or more dispensers 104 and/or patients, such as medication-taking data received from one or more of base station 102, pharmacy 106 and health care provider 108, or compliance data received from base station 102.

A service provider may administer server 110 and system 101 to provide the functionality ascribed herein as a service to one or more pharmacies 106, physicians 108, patients associated with base stations 102 or dispensers 104, or other persons or organizations associated therewith. In some embodiments, server 110 may be administered by a manufacturer of one or more of base stations 104, caps 114 and collars 116. Server 110 may provide web-based interfaces for one or more of pharmacies 106, health care providers 108, patients associated with base stations 102 or dispensers 104, or other persons or organizations associated therewith. Access to such user interfaces may require user authentication, e.g., user name and password. Furthermore, communication with server 110, e.g., communication of patient information, such as medication-taking data and compliance data, may be encrypted.

A health care provider 108, e.g., a physician, writes a prescription for a patient. The health care provider 108 may communicate the prescription to pharmacy 106, e.g., via network 100 and, in some cases, server 102. One or more of the pharmacy 106, health care provider 108, and server 110 may generate medication-taking data based on the prescription and, in some embodiments, transmit the medication-taking data to a dispenser 104 that contains the medication that is the subject of the prescription via network 100 and base station 102. The medication-taking data may be stored within a memory of the dispenser, e.g., within a collar 116 of the dispenser, as described herein.

The medication-taking data stored within dispensers 104 may also be updated in this manner. For example, a patient's medication-taking schedule, i.e., prescription, may change based on changes in the patient's health, or based an analysis of compliance data received from the dispenser 104 and base station 102 via network 100. Such analysis may be performed by one or more of pharmacy 106, health care provider 108, and server 110.

As discussed herein, base station 102 may receive compliance data from one or more dispensers 104 via links 146. Base station 102 may include a user interface to present the compliance data to the patient or another local user. Base station 102 may also transmit the compliance data to one or more of pharmacy 106, health care provider 108, and server 110 via communication link 147 and network 100. In some embodiments, base station 102 may transmit the compliance data to server 110, which may make the compliance data or reports generated based thereon available to other users of system 101, such as pharmacy 106 and health care provider 108. Server 110 may, for example, provide compliance data or reports via email, or make such information accessible via a web-based interface. Server 110 may store such information or reports within a database so that a user may access them at a convenient time.

In various embodiments, as discussed above, medication dispensers 104 may alert the patient that it is time to take a dose of medication based on the medication data stored therein, e.g., within a memory in collar 116. In various embodiments, base station 102 may additionally or alternatively alert the patient that it is time to take a dose. Base station 102 may alert the patient based on medication-taking data stored within base station 102, or a notification received from a dispenser 104. The notification from dispensers 104 or base stations 102 are provided by the various user interfaces described herein with reference to dispensers and base stations, and may take the form of, for example, beeps, tones, flashing lights, audible or visible language, vibration, or the like.

FIG. 16 is a block diagram of another example embodiment of medication compliance system 103 of the present invention. System 103 may be substantially similar to system 101, except system 103 may include a medical device 112. Medical device 112 may be any device capable of providing a therapy to one or more patients, or monitoring one or more parameters of the patient. For example, medical device 112 may be a weight monitor, a blood pressure monitor, or a glucose monitor.

Medical device 112 may communicate with base station 102 via a communication link 146. Base station 102 may receive data from medical device 112, e.g., physiological or other data of a patient measured or collected by the medical device. Base station 102 may display such information to a local user, such as the patient, and transmit such information via network 100 in much the same manner as described above with respect to compliance data. In some embodiments, server 110 may make such information, or reports based thereon, available to users of system 103 in much the same manner as described above with respect to compliance data. While FIG. 16 only shows one medical device 112, various embodiments may have a plurality of different medical devices 112, e.g., for monitoring respective physiological parameters of a patient, each capable of communicating with base station 102.

FIG. 17 is a block diagram of another example embodiment of medication compliance system 105. System 105 may be substantially similar to system 103 except, as shown in FIG. 17, base station 102 may comprise a consumer electronic device, such as a cellular telephone 136 or a personal digital assistant (PDA) 138. Such consumer electronic devices may execute a software application that causes the device to provide the functionality ascribed to base stations 22 and 102 herein.

FIG. 18 is a block diagram of another example embodiment of medication compliance system 107. System 107 is substantially similar to system 101, except that in system 107, in addition to its medical device functionality medical device 112 provides the functionality associated with base stations 22 and 102 herein, e.g., facilitating communication between dispensers 104 and network 100, alerting a patient to take a dose of medication, displaying compliance data, and the like. Medical device 112 may receive compliance data from dispensers 104, and transmit such compliance data, along with physiological or other data collected by the medical device, to one or more of pharmacy 106, health care provider 108, and server 110 via network 100.

FIGS. 19 and 20 respectively are an exploded view and a side, cross-sectional view of an example medication dispenser 104. As described above, medication dispenser 104 comprises a cap 114, a collar 116, and container 118. Collar 116 is located between cap 114 and the opening of container 118. Collar 116 may be substantially permanently affixed to container 118, e.g., unable to be removed without damaging the collar or container.

In various embodiments, collar 116 includes a memory that stores medication-taking data for the medication stored within container 118. Such medication-taking data is used by dispenser 104 to provide alerts or reminders to the patient to take a dose of the medication within container 118. By making collar 116 substantially permanently affixed to container 118, it is less likely that a patient will be able to attach a collar 116 to the wrong container 118. If the wrong collar 116 were attached to a container 118, it would be possible that the dispenser would provide incorrect alerts or reminders to take a dose of the medication within the container, which might cause the patient to take doses that were not prescribed or take doses at the wrong time.

Cap 114 is removably attached, e.g., by mutual threading or friction fit, to collar 116. In this manner, a pharmacist may remove cap 114 from collar 116 to place medication into container, e.g., to fill or refill the patient's prescription. However, the patient need not remove the cap from the collar to take a dose of the medication. Instead, as will be described in greater detail below, and as was the case with dispenser 12 illustrated in FIGS. 13 and 14, cap 114 is able to move relative to collar 116 to expose the opening of container 118 for removal of a dose of the medication from the container. However, whereas the cap in FIGS. 13 and 14 tilted relative to the collar to expose the opening, cap 114 slides in a transverse direction (arrow 121 of FIG. 21B) relative to collar 116 and the longitudinal axis of container 118. Cap 140 may, as illustrated in FIG. 19, be formed to define an indentation to facilitate ergonomic movement of the cap relative to the collar by the patient, e.g., using a thumb.

Cap 114 comprises a top unit 140 with indentation 141, springs 142A and 142B (collectively “springs 142”), and a fixed base 144. Fixed base 144 maintains a fixed position relative to collar 116. As top unit 140 is moved relative to collar 116 to expose the opening of container 118, springs 142 are compressed. After the patient removes the dose, the patient may release top unit 140, at which time the energy stored in springs 142 is released such that the springs move top unit 140 back to the original position relative to collar 116, thereby covering the opening of container 118.

As illustrated in FIG. 20, top unit 140 comprises a circuit board 132 recessed within top unit 140, while collar 116 comprises a circuit board 134. The components and functionality associated with circuit boards 132 and 134 will be described in greater detail below.

FIG. 21A is a block diagram illustrating cap 114 and collar 116 when medication dispenser 104 is closed. FIG. 21B is a block diagram illustrating cap 114 and collar 116 when medication dispenser 104 is open. Board 132 of cap 114 comprises or is coupled to a magnet 124. Board 134 comprises or is coupled to a cap position sensor 126.

When dispenser 104 is closed, i.e., cap 114 is in its original position relative to collar 116 and the opening of dispenser 118 is covered, cap position sensor 126 may detect magnet 124 through the magnetic field generated by magnet 124. When medical dispenser 104 is open, i.e. cap 114 is moved relative to collar 116 to expose the container opening, cap position sensor 126 may not detect magnet 124, e.g., the magnetic field of magnet 124 may be below a sensing threshold. In this manner, cap position sensor 126 may facilitate the detection of whether dispenser has been opened, and thereby detect whether patient has taken a prescribed dose of medication.

Furthermore, the invention is not limited to embodiments in which cap position sensor 126 detects movement of the cap relative to the collar by sensing the movement of magnet 124. In other embodiments, as an example, cap position sensor 126 may comprise a circuit, and cap 114 may include a conductive trace or other circuit element that completes the circuit when the cap is in either the open or the closed position. In such embodiments, cap position sensor 126 may output a signal based on whether the circuit is completed and, in this manner, indicate to a microcontroller of dispenser 104 whether the cap has been moved relative to the collar to dispense a dose of the medication within the dispenser.

FIG. 22 is a block diagram further illustrating cap 114 and collar 116. As illustrated in FIG. 22, circuit board 132 of cap 114 may comprise or be coupled to a communication unit 122, a user interface 120, and, in some embodiments, a magnet 124. Circuit board 134 of collar 116 comprises or is coupled to a microcontroller 128, a memory 130, and cap position sensor 126.

Memory 130 stores medication-taking data. Microcontroller 128 controls user interface 120 to alert/remind the patient to take a dose of the medication within dispenser 104 based on the medication-taking data, e.g., the dose schedule. Microcontroller 128 may detect whether cap 114 has been moved relative to collar, i.e., when dispenser opening has been uncovered for removal of a dose, based on a signal from cap position sensor 126. Microcontroller 128 may store compliance data within memory 130 based on the determination. For example, microcontroller 128 may save the time when medical dispenser 104 was opened within memory 130. Microcontroller 128 may periodically or opportunistically control communication unit 122 to transmit compliance data to base station 102. Microcontroller 128 may also receive medication-taking data from base station 102, or another device, via communication unit 122.

When medical dispenser 104 is closed, i.e., when cap 114 is in its resting position relative to collar 116 and the container opening is covered by the cap, connectors (not shown) on both cap 114 and collar 116 may make contact, allowing an electrical connection between various components in cap 114 to be coupled to components in collar 116. More particularly, the connectors may facilitate connections between circuit boards 132 and 134, to allow microcontroller 128 to communicate with the other components of the dispenser illustrated in FIG. 22.

Microcontroller 128 may comprise any one or more of a microprocessor, application specific integrated circuit (ASIC), or other digital or analog logic circuitry. Memory 130 may comprise any one or more of a random access memory (RAM), read-only memory (ROM), flash memory, or the like. Memory 130 may comprise instructions that, when executed by microcontroller 128, cause the microcontroller to provide the functionality associated with it and dispensers 104 herein. Cap position sensor 126 may comprise, as examples, a Hall-effect sensor, reed switch, or circuit that is completed by a circuit component within the cap. User interface 120 may comprise one or more of a speaker, lights, keys, or a display, e.g., a liquid crystal display. Communication unit 122 may comprise any circuit designed to communicate with base station 102 or network 100 using the media or protocols described above.

The present invention is a device and system that reminds patients to comply with a medication-taking regimen. This is particularly helpful when many medications are being taken and/or when a patient tends to be forgetful. The present invention also allows the physician to track the patient's compliance without having to rely on the patient to do so, and the physician can obtain the compliance data from a remote location.

Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention. 

1. A medication compliance device comprising: a collar for attaching adjacent an opening of a medication container, wherein the collar comprises: a memory that stores medication-taking data, and a sensor; a cap attached to the collar such that the collar is between the cap and the opening, wherein the cap comprises an indicator; and a microcontroller that activates the indicator according to the medication-taking data, determines whether a user responded to the indicator based on a signal from the sensor, and stores the compliance data in the memory of the collar based on the determination.
 2. The device of claim 1, wherein the microcontroller is located within the collar.
 3. The device of claim 1, further comprising a communication unit to transmit the compliance data to a remote locations via a network.
 4. The device of claim 1, further comprising a communication unit to transmit the compliance data to a local base station via local wireless communication.
 5. The device of claim 4, wherein the communication unit transmits the compliance data according to at least one of a Bluetooth, 802.11, or Wibree protocol.
 6. The device of claim 1, wherein the cap is movable relative to the collar to expose an opening of the container for dispensing medication within the container, and the sensor generates the signal based on the movement.
 7. The device of claim 6, wherein the cap is slideable in a transverse direction relative to the collar to expose the opening of the container for dispensing the medication within the container.
 8. A medication compliance device comprising: a collar for attaching adjacent an opening of a medication container, wherein the collar comprises a memory that stores medication-taking data and compliance data; and a cap attached to the collar such that the collar is between the cap and the opening, wherein the cap is movable relative to the collar to expose an opening of the container for dispensing medication within the container.
 9. The device of claim 8, wherein the cap is slideable in a transverse direction relative to the collar to expose the opening of the container for dispensing the medication within the container.
 10. The device of claim 8, further comprising: an indicator; a sensor generates a signal based on the movement of the cap relative to the collar; and a microcontroller that activates the indicator according to the medication-taking data, determines whether a user responded to the indicator based on the signal from the sensor, and stores the compliance data in the memory of the collar based on the determination.
 11. The device of claim 10, wherein the indicator is a visual indicator.
 12. The device of claim 10, wherein the indicator is an audio indicator.
 13. A medication compliance system comprising: a base station; and a portable cap assembly for association with a container of medication, the portable cap assembly comprising: a communication unit for local wireless communication with the base station a memory that stores medication-taking data; an indicator; a sensor; and a microcontroller that activates the indicator according to the medication-taking data, determines whether a patient responded to the indicator based on a signal from the sensor, stores the compliance data in the memory based on the determination, and controls the communication unit to transmit the compliance data to the base station, wherein the base station receives the compliance data from the cap assembly via the local wireless communication, and presents the compliance data to a user.
 14. The system of claim 13, wherein the communication unit transmits the compliance data according to at least one of a Bluetooth, 802.11, or Wibree protocol.
 15. The system of claim 13, wherein the base station transmits the compliance data to a remote location through a data network.
 16. The system of claim 15, wherein the remote location comprises a computing device associated with at least one of a pharmacy or a physician.
 17. The system of claim 15, further comprising a server at the remote location that receives the compliance data, wherein the server makes the compliance data or a report generated based on the compliance data available to a computing device associated with at least one of a pharmacy or a physician.
 18. The system of claim 13, wherein the microcontroller of the portable cap assembly receives the medication-taking data from a remote location via a network, the base station, and the communication unit, and stores the medication-taking data within the memory.
 19. The system of claim 13, wherein the base station further comprises an indicator for indicating when the user should take the dose of medication based on the medication-taking data.
 20. The system of claim 13, wherein the base station comprises at least one of a cellular telephone or a personal digital assistant.
 21. A medication compliance system comprising: a base station; and a portable cap assembly for association with a container of medication, the portable cap assembly comprising: a communication unit for local wireless communication with the base station a memory that stores medication-taking data; an indicator; a sensor; and a microcontroller that activates the indicator according to the medication-taking data, determines whether a patient responded to the indicator based on a signal from the sensor, stores the compliance data in the memory based on the determination, and controls the communication unit to transmit the compliance data to the base station, wherein the base station receives the compliance data from the cap assembly via the local wireless communication, and transmits the compliance data to a remote location via a network.
 22. The system of claim 21, wherein the base station comprises at least one of a cellular telephone or a personal digital assistant.
 23. The system of claim 21, wherein the communication unit transmits the compliance data according to at least one of a Bluetooth, 802.11, or Wibree protocol.
 24. A method of inducing and tracking compliance with a medication-taking regimen, the method comprising: receiving medication-taking data in a portable medication container; alerting a user to take a dose of medication based on the medication-taking data; gathering compliance data in the portable medication container over time regarding consumption of contents of the portable medication container; transmitting the compliance data from the portable medication container to a base station by local wireless communication; and presenting the compliance data to the user via the base station.
 25. The method of claim 24, further comprising: transmitting the compliance data from the base station to a remote location via data network; and accessing the compliance data via the remote location. 